NIH Extramural Research & Funding News

In June, NIH announced plans for a new initiative to provide additional support to the next generation of researchers. We will be announcing policy details this month. Stay tuned to the notices published in the NIH Guide for Grants and Contracts. We will also include an announcement here on the NIH Extramural Nexus & Open Mike blog site, when the policy is published.

Did you know there are three types of Research Performance Progress Reports (RPPRs) that are associated with an NIH grant award? Can you name them? If you said “Annual, Interim, & Final RPPRs”…way to go! What does each one include? How and when do you submit each? What changes have been made in 2017 and what are still to come?

On Wednesday, August 30, from 2:00-3:30 p.m. ET, NIH experts are planning to answer these questions, along with sharing the latest updates on RPPR policies and process updates. This webinar is designed for principal investigators, signing officials, and delegated officials responsible for the development and submission of progress reports to the NIH.

Prior to the webinar, check out the NIH RPPR web page with more “Who? What? And Where?” information.

If you have specific questions or topics you’d like covered, send them by Wednesday, August 23 to OPERAall@nih.gov. These questions and suggestions will be used to help build the presentation content and ensure we’re providing the answers you need. A recording and transcript will be available approximately 5-7 business days following the event on the NIH Grants YouTube channel.

We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human s studies need to ask, and answer. These questions are:

Does the study involve human participants?

Are the participants prospectively assigned to an intervention?

Is the study designed to evaluate the effect of the intervention on the participants?

Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial.

The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. The definition was published in 2014, after extensive public input, and affirmed, after even more public input, in our policy published in September 2016. The clinical trial definition encompasses a wide variety of study types, as shown in figure 1. These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.

Some have argued that we should not expect trial registration and reporting for small or exploratory trials, for trials that focus on safety, or for trials that fail to meet enrollment targets. As we stated last September, NIH chose to emphasize the value of transparency for these kinds of trials as well, as “the benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.” We have an ethical obligation to report results, and this is especially true when volunteers contribute their time as study participants in prospective experiments, whether large or small. And, to be effective stewards of precious and constrained taxpayer monies, we need to collect a minimum of standardized data.

This transparency complements existing efforts to promote data sharing, public access to NIH-funded research results, and scientifically rigorous research design, all of which ultimately benefit the research community directly, as well. By developing and sharing robust data, we maximize the value of NIH’s investment in research by allowing scientists to build upon solid results. The definition, and our clinical trial policies, are an integral part of our efforts to enhance scientific stewardship, dissemination of information, transparency, and to excel as a federal science agency that manages for results.

If you are having difficulty answering the four questions that determine whether a study meets the NIH definition of a clinical trial, we encourage you to consult the case studies and FAQs that are available on our webpage on clinical trial requirements for grants and contracts. We’ll be following up with additional blogs and NIH Extramural Nexus articles that provide more depth on the various initiatives. We strongly encourage you to look at these materials, and share them with your colleagues, to ensure that as an awardee conducting clinical trial research, you are aware of the need to register your trial and report its results.

Did you know that on the day before the two-day seminar, NIH also offers a variety of optional workshops that will help you delve deeper into specific topic areas? On Wednesday, October 25, 2017, you have the opportunity to participate in one or more of the following workshops:

Human Research Reviews: Mastering the Process – Staff from the Department of Health and Human Services Office of Human Research Protections and NIH will provide you with the information necessary to help you get NIH grant applications and research protocols through the review process. In this full day workshop, experts will focus on providing participants with practical tips and solutions to problems and difficulties commonly encountered during such reviews. Note: This workshop does not require participation in the 2-day seminar.

Administrator’s Boot Camp – This introductory level, hands-on workshop for research administrators is designed for those new to applying to NIH. NIH staff will provide in-depth information on the basics of the pre-award process — highlighting key activities, timelines, considerations, and resources. Starting from the very beginning of the pre-award process through the time of award, topics will include registration, identifying funding opportunities, using the application guides, and understanding the Notice of Award.

eRA Workshops (2 options):

Grant Application Preparation & Submission: Are you new to the NIH grant application process or overwhelmed by the logistics of submitting a grant application to NIH? Then this NIH eRA Workshop is for you. We will guide the novice user through all the steps in the application submission process from preparing to apply to verifying your application hasbeen successfully received at NIH.

eRA Commons Account Administration & Post-Submission Processing: Have you recently started a new position or been given an eRA Commons account and you don’t know what to do with it? Then this NIH eRA workshop is for you. In this interactive session, we will guide the novice user through key aspects of account administration, maintaining profiles, and post-submission processing in eRA Commons.

Intellectual Property – Understanding Requirements and Recipient Responsibilities: This beginner to intermediate-level workshop is designed for sponsored program and technology transfer professionals. Participants will gain an understanding of intellectual property, the Bayh-Dole Act, inventions reporting via iEdison, and other award recipient responsibilities as they relate to intellectual property and federal grant funding. Note: This workshop does not require attendance at the two day seminar.

Intellectual Property – A Hands-on Demonstration of iEdison: Join IP experts in this intermediate to advanced-level workshop which will provide participants with a demonstration of Interagency Edison (iEdison), with an emphasis invention and patent reporting, and administration of the patent rights clauses in Federal funding agreements. (This workshop does not require attendance at the two-day seminar.)

Now that the NIH fiscal year 2017 budget is signed into law, NIH published its final fiscal policy and salary cap guidance for this year.

In general, NIH will restore reductions to non-competing continuation awards made this year while we were operating under a pending budget (continuing resolution). Additional details on fiscal operations, including specific funding strategies for ICs and any exceptions, will be posted at the NIH funding strategies page.

The salary cap remains unchanged from the interim guidance published in March. The direct salary limitation follows Executive Level II of the Federal Executive pay scale, which was previously set at $185,100, and increased to $187,000 effective January 8, 2017. This means that for awards issued in previous years that were restricted to Executive Level II, including competing awards already issued in fiscal year 2017, grantees may rebudget to accommodate the current Executive Level II salary level as long as:

adequate funds are available in active awards; and

the salary cap increase is consistent with the institutional base salary.

If you are a researcher who works with animal models, or are involved in IACUCs (Institutional Animal Care and Use Committees), you’ll want to stay on top of news, training opportunities, and resources from the NIH Office of Laboratory Animal Welfare (OLAW). These include:

A fact sheet to get you (or your newer faculty/colleagues) up to speed on principal investigator responsibilities

NIH’s fiscal year 2017 budget was signed into law on May 5. As we do every year, we have posted a list of the current statutory limits on the use of NIH grant, cooperative agreement, and contract awards. Read NIH Guide Notice NOT-OD-17-075 for more information about these legislative mandates.

If you are a recipient of NIH funding, then you are required to report on scientific progress and financial expenditures. Submitting timely, accurate, and complete reports are an essential part of the stewardship of federally-supported research, and maintaining the public’s trust in science.

We recently reminded all NIH recipients of their reporting responsibilities in an NIH Guide notice published June 5. The Guide notice summarizes the required information, and due dates, for Research Performance Progress Reports (RPPRs) and Financial Expenditure –Federal Financial Reports (FFRs).

We encourage you to share this information with your colleagues at your research organization. Failure to submit complete and accurate reports doesn’t just affect one individual – it can affect future funding to the entire organization, and can result in a delay of continued support. Read more in NIH Guide Notice NOT-OD-17-074.

A feature within eRA Commons called the xTRACT module is available to help applicants create training data tables for institutional training grant applications, and to help grantees update these tables for their progress reports (RPPRs).

xTRACT is available to all institutions through eRA Commons. If you or your institution works with institutional training grant applications or progress reports, and are not taking advantage of this tool yet, consider the time-saving features the module provides.

Highlights include:

Using Commons IDs and xTrain appointment data, xTRACT allows users to populate the tables from data already available in the NIH database, including trainee names, selected characteristics, institutions, grant numbers and subsequent NIH and other HHS awards.

After completing and reviewing your data entries, xTRACT produces a PDF file for you to attach to your grant application or RPPR.

Training table data can be reused for future submissions, rather than re-entered manually.

Faculty data can now be bulk uploaded, instead of the previous requirement to add one at a time.

xTRACT validates table entries so that errors can be corrected as the table is being populated.

We’ve received great feedback since xTRACT’s launch in October 2015. xTRACT users say that the system is very helpful in saving time preparing training table information. As of June 2017, xTRACT has been used by more than 160 institutions, with over 110 new applicants using xTRACT for their initial application, and over 1,000 existing grantees using xTRACT for RPPRs and renewals.

While using the xTRACT module is an option, and not yet a requirement, it can save research administrators and principal investigators time when creating and completing data tables for new applications for institutional training grants (T32, TL1, T90/R90, and T15), progress reports, and most types of renewal applications.

Applicants for renewal T90/R90s and other predoctoral, postdoctoral, and career-level training, education, and career development activities that use training data tables (e.g., T35, R25, K12/KL2 awards) can also use xTRACT, but the system does not yet include features tailored to their specific types of awards. Programs targeted to undergraduates (e.g., T34 awards) should not use the xTRACT system at all at this time, but should instead use the fillable tables designed for undergraduate programs available on the NIH website.

“We’re preparing a training grant application but don’t have all the historical data requested in the new data tables, such as the length of prior, full-time research experience for trainees entering the program five years ago. What should we do?”

Because reviewers are asked to assess a training program and its record based, in part, on data presented in the tables, applicants should provide as much data as reasonably possible. Where complete historical data are not available, applicants should indicate that in their applications and begin collecting the relevant information, so that it will be available in the future.

NIH institutional training grant applications request past and present faculty and trainee data, which are used by peer reviewers and NIH program staff in the evaluation of the application and making funding decisions. For active training grants, NIH requests trainee and faculty data to assess the progress of these ongoing training awards. These data provide insight into:

the environment of the proposed training

distribution of participating faculty by research interest

existing support for training, and availability of funds to support trainees’ research

recruitment of new trainees and progress of existing trainees, as assessed by outcomes such as:

There’s only one you, and we want your identification in eRA Commons to represent that! If you have more than one eRA Commons account, look for an email coming your way this summer notifying you of potential duplicate accounts, and providing instructions on how to select your preferred account once you are logged into eRA Commons.

We are beginning this effort in July to support accurate counts of applications and grants, and the proper association of committee service to an investigator. One of the most common reasons for duplicate accounts is when researchers use one login for their peer reviewer role, and another account when submitting an application. We realize you may wear many hats, and the Commons is designed to allow a single account to perform multiple functions, even at more than one organization. For example, a person can have an account with a principal investigator (PI) role at a university, and a PI role at another university or at a small business. The same account may have a trainee role as well as a PI role, as well.

In late July 2017, we will begin sending notifications to individuals who likely have more than one Commons account. For security, these emails will only include instructions on how to determine whether you have duplicate accounts. The process for identifying and selecting the preferred account takes place within eRA Commons, after logging in with your credentials.

Thank you for your time and helping improve the accuracy and reliability of the eRA Commons account data.

At the NIH Regional Seminar this past May, I had the pleasure of giving the keynote talk and presenting different perspectives on how NIH can further the impact of our research funding. Some of the topics I presented in this talk will be familiar to frequent Open Mike blog readers – our concerns about the hypercompetitive nature of applying for NIH support, for example. Others we haven’t discussed in depth here yet – such as how we might measure the contributions of NIH-supported research to treating diseases. My staff recorded this talk and has made it available to you on the NIH Grants YouTube channel. If you’re interested in the topics covered here on the blog (which I hope you are, since you are reading this now!) then you may be interested in this talk.

At the Advisory Committee to the Director meeting last week, NIH Principal Deputy Director Dr. Larry Tabak presented a new NIH initiative to strengthen the biomedical workforce. This presentation followed extensive discussions with stakeholders both here through this blog, at stakeholder meetings, and at NIH advisory council meetings over the last month. We heard unequivocal endorsements for supporting early-career and mid-career researchers given the hypercompetitive funding environment — a challenge we have addressed many times in our blog posts. However, many voiced concerns about our taking a formulaic approach to capping grant funding and called on us to be more direct in enabling greater support for the next generation of biomedical researchers.

For this reason, we have shifted our approach to a focused initiative to support early- and mid-career investigators. As described in a June 8 NIH Director’s statement, and in recognition of the call for such action in the 21st Century Cures Act, we are naming this effort the Next Generation Researchers Initiative. We will take a multi-pronged approach to increase the number of NIH-funded early-stage and mid-career investigators and stabilize the career trajectory of scientists. We describe these approaches on a new web page that we will continue to update. Our activities address both research workforce stability, and evaluation of our investments in research. In brief, NIH will:

commit substantial funds from NIH’s base budget, beginning this year with about $210 million, and ramping to approximately $1.1 billion per year after five years (pending availability of funds) to support additional meritorious early-stage investigators and mid-career investigators

create a central inventory and track the impact of NIH institute and center funding decisions for early- and mid-career investigators with fundable scores to ensure this new strategy is effectively implemented in all areas of research

place greater emphasis on current NIH funding mechanisms aimed at early- and mid-career investigators

aim to fund most early-career investigators with R01 equivalent applications that score in the top 25th percentile

encourage multiple approaches to develop and test metrics that can be used to evaluate the effectiveness of our research portfolio, and assess the impact of NIH grant support on scientific progress, to ensure the best return on investment

Applicants do not need to do anything special to be eligible for this funding consideration. Beginning this fiscal year, the NIH institute or center (IC) who would fund the grant will give your application special consideration for support if you are:

an early-stage investigator (within 10 years of completing your terminal research degree or medical residency and have not previously received a substantial independent NIH research award) and receive a score in the top 25th percentile (or an impact score of 35 if the application is not percentiled)

a mid-career investigator (within 10 years of receiving your first NIH R01 equivalent award) who scores in the 25th percentile, and either:

are at risk of losing all support, or,

are a particularly promising investigator currently supported by a single ongoing award (i.e, NIH will prioritize funding an additional concurrent research project grant award)

NIH ICs make funding decisions to support their mission, and this plan provides flexibility in how ICs will meet the NIH-wide goal of supporting highly scoring early-stage and mid-career researchers. Each IC will make its decisions about how it will prioritize funding to support this initiative.

We appreciate your feedback in addressing the very important issue of stabilizing the biomedical research workforce. Your comments to this blog (or via email, if preferred) are welcome. With the continued input from individuals at every career stage, as well as research institutions and other stakeholders, we can work together to make changes that ensure the long-term stability and strength of the U.S. biomedical research enterprise, and that advance science to improve health for all.

NIH recently updated its policy for what materials will be accepted as post-submission application materials. Beginning with applications submitted for due dates on or after September 25, 2017, citations of newly issued patents can be included in post-submission materials.

The NIH post-submission materials policy allows grant applicants to submit limited information arising from unforeseen events that occur after submission of an application but prior to initial peer review. The updated policy adds citations of issued patents to the list of acceptable post-submission materials. Copies of patent applications or any other materials related to a patent application or issued patent will not be accepted as post-submission materials, unless specified in the Funding Opportunity Announcement (FOA) for which the application was submitted or in a special Guide Notice.

Working with NIH applicants and awardees as an extramural program division director, I often shared the NIH RePORTER resource as a tool for exploring the research topics NIH supports. Learning what projects we support, using a robust database of historical and newly-funded projects (updated weekly), provides researchers valuable insight as they consider developing their own research programs and applications for funding.

Another valuable tool which you might be familiar with is Federal RePORTER, which expands the RePORTER concept to support searching over 800,000 projects across 17 Federal research agencies, with trans-agency data updated annually. As Federal RePORTER recently received an update to introduce some new functions and additional agency data we’d like to highlight some of the ways it helps both the public and scientific researchers alike understand the government’s research portfolio and trace its impact through published articles and patents.

Figure 1

Search or browse data across agencies: Federal RePORTER is designed for ease-of-use. The homepage offers quick search tools for the most commonly used fields, or you can skip the search and use the interactive bar charts and maps on the home page to quickly drill down to projects funded by a certain agency or projects occurring in a particular state. We’ve also added easy-to-follow walkthroughs as “Guided Tour” links on the home page, advanced search page, and results page to learn more. From your search results, you can refine results through links on the sidebar, or read more about individual projects (including a description, and details on the investigator, research organization, and funder.)

Figure 2

Figure 3

Figure 4

Explore search results even further: As with NIH RePORTER, you can export the results for further exploration and analysis, or use the built -in “Charts”, “Map”, or “Topics” tools from the sidebar to learn more about the projects, as in the examples shown below. For example, you can summarize the projects by agency, state, or fiscal year (Figure 2), or map where the research is taking place (Figure 3). You can also explore groups of scientific topics within your search results (for example, a search for “lead” and “drinking water” returns groups of projects covering “ground water”, “ early life”, “arsenic exposure”, and more.) From there, you can drill down into subgroups, to generate lists of projects in that group (Figure 4).

Identify research outcomes: Federal RePORTER aims to link Federal funding to the outcomes of research including publications and patents. Using agency-supplied information, the public can trace the impact of the funding by seeing what academic publications and patents cited the project funding.

With growing resources for identifying agency-supported publications, future plans include expanded coverage of these two important measures of research impact.

These are just a few of the excellent Federal RePORTER features that can help you find collaborators, get to know the research interests of federal science-funding agencies, understand your institution’s sources of support, and prepare your applications and research plan equipped with additional knowledge. We are grateful to all of the federal agencies and offices that provide data and support to Federal RePORTER and make this resource possible. These new functions, additional agency data, and modernized user interface make it easier for you – and all stakeholders in the U.S. scientific enterprise – to learn about the Federal science and engineering portfolio.

Applicants proposing to use established key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment, even if the key resources were purchased or obtained from an outside source that provided data on prior authentication. The authentication plan must include only a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. The plan should be no more than one page. Key resources and the methods for authentication will vary by research field.

For example, applicants proposing to use cell lines should describe the method they plan to use to verify the identity and purity of the lines, which might include short tandem repeat (STR) profiling and mycoplasma testing. Applicants proposing to use chemicals that are key to the research should describe the method used to validate the chemical, which might include liquid or gas chromatography or mass spectrometry. Applicants proposing to use genetically modified animals or cells should describe the method used to confirm the genome modification, which might include PCR amplification or Southern blot. When published consensus standards exist, these may be cited in this section as the procedure(s) that will be used for validation.

Authentication data should not be included in the plan.

NIH recently issued a reminder, highlighting this and other aspects of resource authentication: read NIH Guide Notice NOT-OD-17-068 for details.

The quality of resources used to conduct research is critical to the ability to reproduce the results, so to address scientific rigor in your NIH application, we ask you to include an authentication plan.

Key resources refer to established resources that will be used in the proposed research.

Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Key biological and/or chemical resources may or may not have been generated with NIH funds and:

may differ from laboratory to laboratory or over time;

may have qualities and/or qualifications that could influence the research data; and

are integral to the proposed research.

Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.

Depending on the research study, biological samples may be considered key biological resources that need to be authenticated if they are an established resource, particularly if the investigator received the samples from an outside source.

Each investigator will have to determine which resources used in their research fit these criteria and are therefore key to the proposed research.

NIH recently issued a reminder, highlighting this and other aspects of resource authentication: read NIH Guide Notice NOT-OD-17-068 for details.

We appreciate the many thoughtful comments posted to the blog about working together to improve NIH funding support for early- and mid-career investigators to stabilize the biomedical workforce and research enterprise using a measure called the Grant Support Index (GSI). Some clear themes have emerged, including:

Possible unintentional adverse consequences

Possible deleterious effects on collaborative research

If/how institutional training grants should factor into the GSI

Other ways to support a larger number of scientists

Other approaches to measure PI effort

Discussion of the GSI values (point scale)

Having us look internally at NIH’s intramural program

Based on community feedback from the blog, council meetings, and other discussions with stakeholders, we have made changes to the planned policy to include additional measures beyond GSI to strengthen NIH funding support for early-and mid-career investigators. We will also provide greater flexibility in the use of GSI as a measure for guiding NIH funding decisions, and will make other changes to be sure that this approach does not discourage collaboration and training. These updates will be presented at the June meeting of the NIH Advisory Committee to the Director. We encourage you to tune in via NIH videocast to the presentation on Thursday, June 8.

To provide us with additional feedback, please post comments to this blog or send an email to PublicInput@od.nih.gov.

If you missed joining 850 of your peers in New Orleans this May, don’t worry! You still have one more chance in 2017 to participate in the NIH Regional Seminar on Program Funding and Grants Administration, a unique opportunity to learn more about the NIH process and hear the latest policies directly from over 65 NIH & HHS experts. Over 30 additional NIH Institute and Center staff will be on hand to talk with you in person during our 1:1 Meet the Expert chats, plus you’ll want to stop by our NIH and industry exhibits for more helpful information. Make plans now for the upcoming seminar in Baltimore, Maryland from October 25-27. But wait… there’s more good news! Through June 9, you can save on registration with our “early bird” seminar rate. Act now and don’t forget to reserve your hotel room too while the discounted room block for seminar attendees is still available!